Dicloxacillin Sodium

Product NDC: 0093-3125
11-digit product format: 000933125
Labeler code: 0093
Product ID: 0093-3125_1976304d-7c32-40f7-9724-0d1903dad50e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicloxacillin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA062286
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: DICLOXACILLIN SODIUM
Active strength: 500 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062286-001	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03
A062286-002	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062286-001	AB
A062286-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB		1982-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062286-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A062286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062286-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A062286-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062286-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062286-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062286-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062286-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062286-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062286-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062286-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062286-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062286-002	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dicloxacillin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOXACILLIN SODIUM	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4HZT2V9KX0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197595	Internal RxNorm lookup
197596	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8478f242-c715-4984-ac1d-dc79dc28665e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7f6212-eff4-e8f0-b733-f4aa5877dfa0	Product name	2	20231211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-3125-01	Dicloxacillin Sodium	100 in 1 BOTTLE	CAPSULE	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3125-01	EA - Each	0093-3125	0f32c12d-55e6-4925-bc6f-ea883cbf8652	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA INC]	4
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
DICLOXACILLIN SODIUM	ACTIVE INGREDIENT	4HZT2V9KX0	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
DICLOXACILLIN	ACTIVE MOIETY	COF19H7WBK	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-3125	DICLOXACILLIN SODIUM CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20241113_8478f242-c715-4984-ac1d-dc79dc28665e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	Chartwell RX, LLC	270c0839-c30c-475d-a505-e70855652c9e	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c17cd62d-ff5d-47ba-8673-3346c7f2365f	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	9e2bbe03-44cb-45d1-acdb-b61d9016055e	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	24e821aa-85b8-4f5a-aa13-83ff132952ca	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Bryant Ranch Prepack	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Teva Pharmaceuticals USA, Inc.	8478f242-c715-4984-ac1d-dc79dc28665e	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286 ndc (product): 0093-3125
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Asclemed USA, Inc.	a4174fda-68f7-4834-be58-dd6b167cf9f0	2020-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4HZT2V9KX0	DICLOXACILLIN SODIUM	13412-64-1	DICLOXACILLIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	102
197596	dicloxacillin 500 MG Oral Capsule	SCD	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	102
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	102
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	24e821aa-85b8-4f5a-aa13-83ff132952ca	16
197596	dicloxacillin 500 MG Oral Capsule	SCD	24e821aa-85b8-4f5a-aa13-83ff132952ca	16
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	24e821aa-85b8-4f5a-aa13-83ff132952ca	16
197595	dicloxacillin sodium 250 MG Oral Capsule	PSN	8478f242-c715-4984-ac1d-dc79dc28665e	12
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	8478f242-c715-4984-ac1d-dc79dc28665e	12
197595	dicloxacillin 250 MG Oral Capsule	SCD	8478f242-c715-4984-ac1d-dc79dc28665e	12
197596	dicloxacillin 500 MG Oral Capsule	SCD	8478f242-c715-4984-ac1d-dc79dc28665e	12
197595	dicloxacillin (as dicloxacillin sodium) 250 MG Oral Capsule	SY	8478f242-c715-4984-ac1d-dc79dc28665e	12
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	8478f242-c715-4984-ac1d-dc79dc28665e	12
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	3dbcccb5-5a36-45cf-e054-00144ff8d46c	4
197596	dicloxacillin 500 MG Oral Capsule	SCD	3dbcccb5-5a36-45cf-e054-00144ff8d46c	4
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	3dbcccb5-5a36-45cf-e054-00144ff8d46c	4
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	2861a407-7898-489d-a43c-1e316341863e	1
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	e12a13dd-b93d-452c-8671-aec751ddaa4d	1
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	a4174fda-68f7-4834-be58-dd6b167cf9f0	1
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	3393668f-ea58-442e-b293-c7107b69d1af	1
197596	dicloxacillin 500 MG Oral Capsule	SCD	2861a407-7898-489d-a43c-1e316341863e	1
197596	dicloxacillin 500 MG Oral Capsule	SCD	3393668f-ea58-442e-b293-c7107b69d1af	1
197596	dicloxacillin 500 MG Oral Capsule	SCD	a4174fda-68f7-4834-be58-dd6b167cf9f0	1
197596	dicloxacillin 500 MG Oral Capsule	SCD	e12a13dd-b93d-452c-8671-aec751ddaa4d	1
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	3393668f-ea58-442e-b293-c7107b69d1af	1
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	a4174fda-68f7-4834-be58-dd6b167cf9f0	1
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	2861a407-7898-489d-a43c-1e316341863e	1
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	e12a13dd-b93d-452c-8671-aec751ddaa4d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3125-01	00093312501	100 CAPSULE in 1 BOTTLE (0093-3125-01)	100 capsule	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicloxacillin Sodium Capsules USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	16
Dicloxacillin Sodium Capsules USP Rx only	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	26
Dicloxacillin Sodium Capsules USP Rx only	REMEDYREPACK INC.	2024-10-17	HUMAN PRESCRIPTION DRUG LABEL	1
Dicloxacillin Sodium Capsules USP Rx only	Bryant Ranch Prepack	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	102
Dicloxacillin Sodium Capsules USP Rx only	Teva Pharmaceuticals USA, Inc.	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	12
DICLOXACILLIN SODIUM CAPSULES USP 3123 3125 Rx only	NuCare Pharmaceticals, Inc. \| NuCare Pharmaceuticals, Inc.	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Dicloxacillin Sodium Capsules USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-11-14	HUMAN PRESCRIPTION DRUG LABEL	1
Dicloxacillin Sodium Capsules USP Rx only	AvKARE, Inc.	2018-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
DICLOXACILLIN SODIUM CAPSULES USP 3123 3125 Rx only	A-S Medication Solutions	2017-12-08	HUMAN PRESCRIPTION DRUG LABEL	6
DICLOXACILLIN SODIUM CAPSULES USP 3123 3125 Rx only	H.J. Harkins Company, Inc. \| TEVA Pharmaceuticals USA Inc	2011-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
DICLOXACILLIN SODIUM CAPSULES USP 3123 3125 Rx only	RedPharm Drug Inc. \| TEVA Pharmaceuticals USA Inc	2011-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Dicloxacillin Sodium - STAT RX USA LLC	STAT RX USA LLC	2011-02-23	HUMAN PRESCRIPTION DRUG LABEL	1